FDA applicant

Island Dental Lab, Inc Dba Emerald Dental

Valley Stream, NY1 decision2023–20230 recalls

FDA records 1 decision for Island Dental Lab, Inc Dba Emerald Dental (Valley Stream, NY) in 2023: 1 510(k) clearance. All are in product code LRK (Device, Anti-Snoring). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Island Dental Lab, Inc Dba Emerald Dental’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Island Dental Lab, Inc Dba Emerald Dental by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Island Dental Lab, Inc Dba Emerald…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Island”

FDA records each applicant name separately; these may or may not be the same firm.

Island Biosurgical, Inc. 4 Island Medical 2 Island Critical Care Corp. 1 Island Dressing, LLC 1

Island Dental Lab, Inc Dba Emerald Dental

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Island”